Brain Changes in Psoriasis After Secukinumab Treatment
Primary Purpose
Psoriasis, Healthy
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Secukinumab
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis
Eligibility Criteria
Inclusion:
- Between 18 and 65 years of age.
- Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more than 5%.
- Psoriasis patients must have had a TB test in the past 8 months (if a patient has not had one, the study will provide one).
- Healthy subjects: in general, good health without history of neurological and psychiatric diseases. No chronic itch, pain, skin or systemic conditions currently or in the past.
- Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
- MRI Compatibility: No major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form.
- Participants have to be able to speak and read English fluently.
- Participants must have signed a written informed consent before being enrolled in the study
Exclusion:
- Individuals under 18 or over 65 years of age.
- Inability to complete the required measures.
- Participants who use antihistamine drugs for itch relief
- Suffering from any disease state or physical condition, which would increase their health risk by study participation.
- Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections and chronic tuberculosis) or inflammatory bowel disease.
- Patients without a negative TB test in the past 12 months.
- Hypersensitivity or anaphylaxis to biologics
- Patients with treatment of biologics should not receive live vaccines. Thus, age appropriate immunizations according to current immunization guidelines must be completed before the experiment.
- Patients with primary immunodeficient lacking IL-17, patients with autoantibodies against IL-17
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
- Recent initiation (within last 3 months) or change in dose of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.
- Patients who were previously treated with drugs targeting IL-17
- Patients who have used biologics in the past in the past 8 weeks or Otezla in the past 4 weeks.
- Patients who use centrally acting agents only when they need. The purpose is to avoid a risk of acute effect of these agents on brain activity.
- Current treatment with opioid analgesics.
- Uncontrolled thyroid disease.
- Use of illicit drugs or history of opiate addiction.
- Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active currently.
- Morbid obesity
- Weight: 250 lb or more
- Any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., HIV, Hepatitis C, etc).
- Inability to speak and read English.
- Pregnant.
- Incarcerated.
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psoriasis Group
Healthy Group
Arm Description
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Healthy participants will not receive any intervention.
Outcomes
Primary Outcome Measures
Change in gray matter density
Changes in brain anatomy for psoriasis participants will be reported as the change in gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans
Change in brain activity
Changes in brain activity in psoriasis participants will be measured using Arterial Spin Labeling (ASL) MRI
Secondary Outcome Measures
Change in itch score as measured by the NRS
Itch will be measured using the Numerical Rating Scaling (NRS) ranging from 0 (no itch) to 10 (the worst itch imaginable).
Change in pain score as measured by the NRS
Pain will be measured using a Numerical Rating Scaling (NRS) ranging from 0 (no pain) to 10 (the worst pain imaginable).
Change in PASI scores
Severity of psoriasis will be measured using the Psoriasis Area and Severity Index (PASI), ranging from 0 to 100, with a higher score indicating more severe psoriasis.
Change in participant well-being as measured by WHO-5
Well-being will be measured using the 5-item World Health Organization Well-Being Index (WHO-5), ranging from 0 to 25, with a higher score indicating better well-being.
Change in quality of sleep as measured by PSQI scores
Quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 49, with a higher score indicating lower sleep quality.
Change in physical activity as measured by 7D-PAR
Physical activity will be measured using the 7-days physical activity recall (7D-PAR), ranging from 0 to 27, with a higher score indicating more physical activity.
Changes in stress in daily life as measured by PSQ
Stress in daily life in psoriasis participants will be measured using the Perceived Stress Questionnaire (PSQ), ranging from 0 to 1, with a higher score indicating more stress.
Full Information
NCT ID
NCT04717466
First Posted
January 15, 2021
Last Updated
January 18, 2023
Sponsor
University of Miami
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT04717466
Brief Title
Brain Changes in Psoriasis After Secukinumab Treatment
Official Title
Brain Morphological Changes Accompanied by Effective Biologic Treatments for Psoriasis and Their Associations With the Improvement of Well-being, Itch, and Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity and examine whether the plastic changes correlate with the improvement of perception of well-being, itch, and pain in participants with psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psoriasis Group
Arm Type
Experimental
Arm Description
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Arm Title
Healthy Group
Arm Type
No Intervention
Arm Description
Healthy participants will not receive any intervention.
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Intervention Description
300mg subcutaneous injection
Primary Outcome Measure Information:
Title
Change in gray matter density
Description
Changes in brain anatomy for psoriasis participants will be reported as the change in gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans
Time Frame
Baseline, Up to Week 4 (Visit 3)
Title
Change in brain activity
Description
Changes in brain activity in psoriasis participants will be measured using Arterial Spin Labeling (ASL) MRI
Time Frame
Baseline, Up to Week 4 (Visit 3)
Secondary Outcome Measure Information:
Title
Change in itch score as measured by the NRS
Description
Itch will be measured using the Numerical Rating Scaling (NRS) ranging from 0 (no itch) to 10 (the worst itch imaginable).
Time Frame
Baseline, Up to Week 4 (Visit 3)
Title
Change in pain score as measured by the NRS
Description
Pain will be measured using a Numerical Rating Scaling (NRS) ranging from 0 (no pain) to 10 (the worst pain imaginable).
Time Frame
Baseline, Up to Week 4 (Visit 3)
Title
Change in PASI scores
Description
Severity of psoriasis will be measured using the Psoriasis Area and Severity Index (PASI), ranging from 0 to 100, with a higher score indicating more severe psoriasis.
Time Frame
Baseline, Up to Week 4 (Visit 3)
Title
Change in participant well-being as measured by WHO-5
Description
Well-being will be measured using the 5-item World Health Organization Well-Being Index (WHO-5), ranging from 0 to 25, with a higher score indicating better well-being.
Time Frame
Baseline, Up to Week 4 (Visit 3)
Title
Change in quality of sleep as measured by PSQI scores
Description
Quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 49, with a higher score indicating lower sleep quality.
Time Frame
Baseline, Up to Week 4 (Visit 3)
Title
Change in physical activity as measured by 7D-PAR
Description
Physical activity will be measured using the 7-days physical activity recall (7D-PAR), ranging from 0 to 27, with a higher score indicating more physical activity.
Time Frame
Baseline, Up to Week 4 (Visit 3)
Title
Changes in stress in daily life as measured by PSQ
Description
Stress in daily life in psoriasis participants will be measured using the Perceived Stress Questionnaire (PSQ), ranging from 0 to 1, with a higher score indicating more stress.
Time Frame
Baseline, Up to Week 4 (Visit 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion:
Between 18 and 65 years of age.
Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more than 5%.
Psoriasis patients must have had a TB test in the past 8 months (if a patient has not had one, the study will provide one).
Healthy subjects: in general, good health without history of neurological and psychiatric diseases. No chronic itch, pain, skin or systemic conditions currently or in the past.
Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
MRI Compatibility: No major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form.
Participants have to be able to speak and read English fluently.
Participants must have signed a written informed consent before being enrolled in the study
Exclusion:
Individuals under 18 or over 65 years of age.
Inability to complete the required measures.
Participants who use antihistamine drugs for itch relief
Suffering from any disease state or physical condition, which would increase their health risk by study participation.
Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections and chronic tuberculosis) or inflammatory bowel disease.
Patients without a negative TB test in the past 12 months.
Hypersensitivity or anaphylaxis to biologics
Patients with treatment of biologics should not receive live vaccines. Thus, age appropriate immunizations according to current immunization guidelines must be completed before the experiment.
Patients with primary immunodeficient lacking IL-17, patients with autoantibodies against IL-17
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Recent initiation (within last 3 months) or change in dose of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.
Patients who were previously treated with drugs targeting IL-17
Patients who have used biologics in the past in the past 8 weeks or Otezla in the past 4 weeks.
Patients who use centrally acting agents only when they need. The purpose is to avoid a risk of acute effect of these agents on brain activity.
Current treatment with opioid analgesics.
Uncontrolled thyroid disease.
Use of illicit drugs or history of opiate addiction.
Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active currently.
Morbid obesity
Weight: 250 lb or more
Any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., HIV, Hepatitis C, etc).
Inability to speak and read English.
Pregnant.
Incarcerated.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hideki Mochizuki, PhD
Phone
305-243-1648
Email
hxm414@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leigh Nattkemper, PhD
Phone
305-588-9734
Email
Lxn202@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Yosipovitch, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideki Mochizuki, PhD
Phone
305-243-1648
Email
hxm414@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Gil Yosipovitch, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Brain Changes in Psoriasis After Secukinumab Treatment
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